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LY3962681

Phase 1

Parkinson's Disease | Small molecule | Neurology |Eli Lilly and Company|Last Updated: May 18, 2026

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment124
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06565195A Clinical Trial of LY3962681 in Healthy Volunteers and in Patients With Parkinson's DiseasePHASE1 RECRUITING 124Aug 27, 2024May 5, 2029May 18, 20264 United States, Japan
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Study Endpoints
Primary Endpoints
Incidence of Serious Adverse Events (SAEs)
Up to 76 weeks
Incidence of Treatment Emergent Adverse Events (TEAEs)
Up to 76 weeks
Number of discontinuations due to Adverse Events (AEs)
Up to 76 weeks
Secondary Endpoints
LY3962681 Maximum Observed Concentration (Cmax)
Up to 76 weeks
LY3962681 area under the concentration versus time curve (AUC)
Up to 76 weeks
Change from baseline in CSF total alpha-synuclein
Up to 76 weeks
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Study Design & Arms
AllocationRANDOMIZED
MaskingDOUBLE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
LY3962681 (SAD)EXPERIMENTALSingle ascending dose of LY3962681 or placebo (aCSF) administered intrathecally (IT) to healthy volunteers.
LY3962681 (MAD)EXPERIMENTALMultiple ascending doses of LY3962681 or placebo (aCSF) administered IT to participants with Parkinson's disease.
Interventions
NameTypeDescription
LY3962681DRUGIT injection
Placebo (aCSF)OTHERIT injection
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Eligibility Criteria
Age Range30 Years — 80 Years
SexALL
Healthy VolunteersYes
Study Sites4

Inclusion Criteria: * Participant is overtly healthy as determined by medical evaluation. Rescreening is allowed in this study. * A Montreal Cognitive Assessment score greater than or equal to 24. * Stable use of background medications at least 8 weeks prior to IP administration, including but not ...

Countries:United StatesJapan
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT06565195Enrollment: 108 → 124
LOWMay 24, 2026NCT06565195studyFirstPostDate: changed